INSTRUCTION MANUAL

Topographic Modeling System

TMS-4N

Carefully read this instruction manual before using this

instrument to ensure correct and safe operation. If you have
questions about operations, please contact Tomey
Corporation or our local distributor.
Always follow the operation procedures described
in this manual.
Keep this manual in a readily available location
while operating the instrument.
Contact our local distributor if you lose this
instruction manual.

22CA9090-0B

i.

IMPORTANT SAFETY INFOMATION

DO NOT install this instrument in such a place where explosives or

inflammables are used or stored. A fire or an explosion may result.
DO NOT remove the cover of the instrument. You may directly be exposed to
high electric voltage.
DO NOT disassemble nor modify the instrument. You may directly exposed to
high electric voltage.
DO NOT stare into the laser beam for alignment irradiated from the measuring
head.
The personal computer specified in this manual and an isolation transformer
that isolates the power source for the personal computer from the commercial
power source are required to use this instrument. Be sure to observe the
following precautions related to your personal computer and isolation
transformer in order to safely use them as part of this medical equipment
system. Refer to 8. Specifications for the performance requirements of the
personal computer and isolation transformer. Contact our local distributor or
Tomey Corporation if you have any questions.
Pull off the power cable from the instrument at its maintenance.
Use a personal computer conforming to IEC60950-1 and an isolation
transformer conforming to IEC60601-1.Otherwise, they may not function
safely as part of this medical equipment system.
Connect the power cord of the personal computer to the isolation transformer,
not directly to a commercial power source. Otherwise, they may not function
safely as part of this medical equipment system.
Do not place the isolation transformer directly on the floor when in use.
Do not connect a plug-in socket or extension cord to the isolation
transformer.

i-1

 DO NOT put water or chemicals on the instrument. An electric shock or a

failure may result if those get into the instrument.
DO NOT connect other things than the specified to avoid possible failure.
Do not connect electrical appliances not provided in the system package to
the isolation transformer. Otherwise, failure may occur in the isolation
transformer or electrical appliances.
This instrument is a diagnostic/measuring device specially designed for
ophthalmology. DO NOT use it for other purposes.
Output terminals are NOT isolated from the inner circuits. Wrong
connection may break the inner circuits. Consult us for use of the output
terminals.
When operating this instrument connected to other devices, only use devices
that satisfy IEC60601-1 or equivalent safety requirements, or that conform to
IEC60950 and whose power source is insulated with the isolation transformer
provided with the instrument, in order to satisfy the relevant safety
requirements for medical equipment.
The total rated input of devices to be connected to the isolation transformer is
less than 500 VA. Use the transformer to supply power only to devices
intended to comprise part of the system.
Do not connect the power source of the personal computer connected to this
instrument for operation directly to the socket on the wall. Otherwise, electric
shock or failure may occur.

i-2

ii.

How to read this manual

Outline
The Operator Manual is composed of the following parts.
1. PRIOR TO USE
Describes safety precautions and important information to be understood before
installing and using the instrument.

2. NAMES AND FUNCTIONS

Describes names and functions of each section of the instrument.

3. OPERATION PROCEDURES
Describes information required for installing and using the instrument.

4. TECHNICAL INFORMATION
Describes useful technical information about the instrument.

5. INSPECTION AND MAINTENANCE

Describes procedures for replacing consumable parts, etc. that the user of the instrument
should normally conduct.

6. TROUBLESHOOTING
Describes how to solve problems.

7. CONSUMABLES AND OPTIONAL EQUIPMENT

Describes consumable parts and optional equipment.

8. SPECIFICATIONS
Describes the specifications of the instrument.

ii-1

SYMBOLS USED IN THIS MANUAL

Descriptions accompanied by the symbols below indicate the following:

This is a precaution that, if unheeded, will result in a hazardous situation
where there is an imminent danger of serious injury or death.

This is a precaution that, if unheeded, could result in a hazardous

situation where there is a possibility of serious injury or death.

This is a precaution that, if unheeded, may result in a situation where there is

a possibility of minor or moderate injury or damage to property.

This is additional information which may contain special precautions on

company policies related, either directly or indirectly, to the safety of
personnel or to the protection of property.

ii-2

iii.

CONTENTS

i.

IMPORTANT SAFETY INFOMATION.................................................................................................................. i-1

ii.

How to read this manual................................................................................................................................. ii-1

Outline .................................................................................................................................................................... ii-1
SYMBOLS USED IN THIS MANUAL ..................................................................................................................... ii-2

iii.

CONTENTS ..................................................................................................................................................... iii-1

1.

PRIOR TO USE................................................................................................................................................. 1-1

1.1
1.2
1.3
1.4
1.5

2.

NAME AND FUNCTIONS ................................................................................................................................. 2-1

2.1
2.2
2.3
2.4

3.

Corneal Refractive Index ........................................................................................................................... 4-1

Simulated K Values.................................................................................................................................... 4-1
Alignment and Pupil offsets ....................................................................................................................... 4-1
Fourier analysis ......................................................................................................................................... 4-2

INSPECTION AND MAINTENANCE ................................................................................................................ 5-1

5.1
5.2
5.3
5.4
5.5
5.6
5.7

6.

Safety precautions ..................................................................................................................................... 3-1

Initial Setup.............................................................................................................................................. 3-3
Main Screen ............................................................................................................................................. 3-4
Patient Record ......................................................................................................................................... 3-14
Capture Screen (Picture Taking) ............................................................................................................. 3-16
PreMap Screen ........................................................................................................................................ 3-20
Exam Screen (Analysis) .......................................................................................................................... 3-20
Map Screen ............................................................................................................................................. 3-26
Map Options ............................................................................................................................................ 3-40
Other Map Display Methods and Applications .................................................................................. 3-48
Utilities .................................................................................................................................................... 3-60

TECHNICAL INFORMATION ........................................................................................................................... 4-1

4.1
4.2
4.3
4.4

5.

Front side of the Instrument (Physicians side) ....................................................................................... 2-1

Rear of the instrument (patient's side) ....................................................................................................... 2-2
Icons on the screen ................................................................................................................................ 2-3
Symbols ..................................................................................................................................................... 2-4

OPERATION PROCEDURES.......................................................................................................................... 3-1

3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11

4.

Precautions for use ................................................................................................................................. 1-1

Checking package contents ...................................................................................................................... 1-5
Glossary..................................................................................................................................................... 1-6
Intended use .............................................................................................................................................. 1-9
Outline of operation ............................................................................................................................... 1-9

Warranty .................................................................................................................................................... 5-1

Operation life ............................................................................................................................................. 5-2
Inspection .................................................................................................................................................. 5-2
Routine maintenance ................................................................................................................................. 5-3
Replacing consumables ............................................................................................................................ 5-4
Storing........................................................................................................................................................ 5-5
Disposal ..................................................................................................................................................... 5-5

TROUBLESHOOTING ...................................................................................................................................... 6-1

6.1
6.2

TROUBLESHOOTING .............................................................................................................................. 6-1

Error and solution ...................................................................................................................................... 6-3

iii-1

7.

CONSUMABLES AND OPTIONAL EQUIPMENT ........................................................................................... 7-1

8.

SPECIFICATIONS ............................................................................................................................................ 8-1

8.1
8.2
8.3
8.4
8.5

iii-2

Specifications ............................................................................................................................................. 8-1

Noises ........................................................................................................................................................ 8-2
Environmental Condition ........................................................................................................................... 8-3
Classification.............................................................................................................................................. 8-3
Declaration of Conformity to EMC ............................................................................................................. 8-4

1. PRIOR TO USE
Read this Instruction Manual carefully and thoroughly
before using the Instrument for your proper and safe
operation.
Do not use any operation
prescribed in this Manual.

procedures

other than

Make sure that there is no device generating strong

magnetic field. It could be a cause of noise which may make
incorrect measurement.

1.1

Precautions for use

This instrument must be operated only by skilled operator.
Note the followings when installing this instrument.
- Do not set up in a place where water or chemicals are near it. If those get in the
instrument, an electric shock or a failure may result.
- Do not set up in a place where chemicals are stored or gas is produced. If those
get in the instrument when they are spilled or evaporated, a fire may result.
- Note the frequency, the voltage and the permissible current value ( or power
consumption) of the power supply. If the instrument is run by any other power,
a fire or an electric shock may result.
- Be sure to connect the power plug to the outlet with a ground cable for a
three-prong plug. In case of a leakage due to a failure, an electric shock may
result.
- Do not put any heavy stuff on or pinch the power cable. A fire or an electric
shock may result.
- Be sure to connect the power plug all the way in. When the connection is loose
or when the metal touches or when dust gathers in the terminal of an exposed
plug, a fire or an electric shock may result.
- Do not connect the instrument to other devices which have different data
transfer protocol. A fire or an electric shock may result. Be sure to contact our
local distributor when you connect some devices to the communication
terminal.
- Connect the ground cable properly. Or an electric shock may result.
- Do not hold the head, chin rest, forehead pad, or joystick when moving the
instrument. These components are detachable and the instrument may drop,
resulting in injuries.
- Do not set up in a place where it gets direct sunlight, the place with high
temperature and humidity or the place where the negative effect may occur by
air containing dust, salinity, sulfur or a failure or malfunction may result.
- Set up in a place without inclination, vibration, impact, or test result may not be
accurate. Also, a fire or an accident resulting in injury or death may result from
falling or dropping.

1-1

- Set up in a place where the patient and the examiner can face each other
across the instrument.
- Set up in a place far enough from other equipment(s) when malfunctioning.
Note the followings before use
- Be sure that all the cables are connected properly and perfectly.
- Check that the instrument works properly by inspecting switch operations and
the display.
- Be careful when using other equipments beside this instrument because
incorrect diagnosis or danger may result.
- Check again the part which directly touches the patient.
- Peel off the top sheet of chin rest paper and clean the forehead pad with a
cloth dampened with alcohol before measurement.
- Check if the ground cable is surely connected.
- Check that the date set in the personal computer conforms to the actual
operation date and time.
Note the followings during the use.
- Do not put a bottle or something containing some liquid in it. An electric shock
or a failure may result.
- Be sure to touch the New Patient button to delete the measurement data for
the previous patient before measuring a new patient. If any new measurement
is started without deleting the previous data, the measurement data for the
previous patient may be included.
- When moving the measuring head and/or chin rest of the instrument, pay
attention to the position of the patient's face, hands, and fingers. The patient
may be injured by the moving section of the instrument.
- Do not allow any person to place their hands or fingers in the clearance under
the measuring head or the section under the chin rest
- Be extremely careful not to take too much time as this can stress the patient.
- Keep the patients hands or fingers off the opening of the measuring part.
Injury may result by getting them pinched.
- Do not lean against the instrument or put any pressure on it. It may fall leading
a failure or injury.
- Do not spend too much time in measurement.
- Do not allow the patient to touch the instrument.
- Always check if there is any abnormality in the instrument and the patient.
- When any abnormality is found in the instrument and the patient, discontinue
testing immediately and take appropriate measures.
- When smoke, odor or abnormal noise comes out of the instrument, turn ION.
- If problems such as smoke, offensive odor, or abnormal sound occur,
immediately turn off the instrument, disconnect the power plug from the outlet,
and contact Tomey Corporation or our local distributor.

1-2

- When smoke, odor or abnormal noise comes out of the instrument, turn off the
power immediately, pull out the power plug from the outlet and contact the
place of purchase or TOMEY CORPORAT- Keep the patients hands or fingers
off the opening of the measuring part. Injury may result by getting them
pinched.
- When the mires do not trace the projected rings precisely, incorrect analysis
may result. For example, the color map of the right eye is much different from
the let eye or the center part of the eye differs very much from the peripheral
(too steep or too flat). In these cases diagnosis must be made not only with the
result of this instrument but also with other information. Diagnosing only with
the result of this instrument may result re-operation.
- Only use the ring cone provided for this instrument. Otherwise, the correct
corneal shape or curvature cannot be obtained. The number attached to the
ring cone must be identical to the number attached to the inside of the main
unit which can be seen when the ring cone is detached.
- Do not look directly at the laser beam when performing alignment. Otherwise,
the patient may suffer damage to their vision.
- Be careful not to touch the patient and any of the following sections
simultaneously.
- USB terminal
- Metallic part of fuse holder
- Personal computer
- Monitor
- Peel off the top sheet of chin paper and clean the forehead pad with a clean
cloth before capturing images for the next patient. Clean the forehead pad and
chin rest with a cloth dampened with alcohol as needed.
Note the followings after use
- Do not put a bottle or something containing some liquid in it. An electric shock
or a failure may result.
- Do not use organic solvents such as thinner, benzene, or acetone to clean the
instrument. Fire or electric shock may occur, or parts may be discolored or
damaged, resulting in faulty measurements.
- When pulling out the power plug from the outlet, pull it out surely from the base
of the plug so as not to apply excessive force on the cable. When the cable is
pulled, the wires inside of the cable may be cut off and result an electric shock
or a fire.
- When disconnecting cords, do not apply too much force to them, for example,
do not hold and pull the cord.
- To clean and to store this instrument, see 5.2 Routine Maintenance and 5.3
Storing as described later.
- Clean the instrument at the end of operation in preparation for the next use.
- Clean and neatly arrange the accessories and cables.

1-3

 If the instrument fails to work properly, discontinue immediately and

contact the place of purchase for checks and repairs.
- Do not modify this instrument, or an electric shock or a failure may result. The
instrument has a part containing high voltage which may lead to an electric
shock. If you touch that part, death or severe injury may result.
- When the instrument fails to work properly, contact the place of purchase for
checks and repairs without tampering with it.
- Make sure to check this instrument and parts periodically.
- When the instrument is not used for 1 month or longer, check that the
instrument is operating correctly and safely before starting operation. Refer to
"5.3 Inspection" in this manual for the checking procedures.

1-4

1.2

Checking package contents

Open the package and check that the required quantity of the following items is included and they
are not damaged. If any item is missing or damaged, contact our local distributor as soon as
possible.
Keep the box and packing materials for use when moving or
transporting the instrument.
When taking the instrument out of the box, pull the outer
box upward and then remove the packing materials. Be
careful not to lift the instrument by directly holding the
measuring head, chin rest, forehead pad, or joystick. The
instrument may be damaged.
Main unit Topographic Modeling system TMS-4N 1
Cone (25 rings) ................................................... 1
Model eye (for 25 rings) ...................................... 1
Power cable ........................................................ 1
USB cable ........................................................... 1
Fuses.................................................................. 2
Chin rest paper ................................................... 1
Chin rest pin. ...................................................... 2
CD-R disk (TMS-4N software) ............................ 1
Dust cover .......................................................... 1
INSTRUCTION MANUAL (this manual) ............ 1
Software setup guide .......................................... 1
< Following parts are added to the CL option >
Cone (31 rings) ................................................... 1
Model eye (for 31 rings) ...................................... 1
Contact lens wizard ............................................ 1

1-5

1.3

Glossary
The main terminology used for the Instrument or its operation mentioned in this Manual will be
explained in the following.
[Rx only]

This symbol on the label of this device states "Caution: Federal

law restricts this device to sale by or on the order of a licensed
healthcare practitioner."

[D]

Diopter (unit which shows the refractive power, inverse number

of meter)

[Picture Perfect]

Function of the TMS Series which automatically corrects the

errors caused by axial alignment in the left/right (X-axis),
up/down (Y-axis), and front/rear (Z-axis) directions. The Picture
Perfect is also intended to display maps asmuch correctly as
possible.

The Picture Perfect takes and displays laser alignment beams

as well as corneal topography. Data taken and analyzed with the
Picture Perfect as turned for (PP/ON) automatically analyzes
and corrects errors caused with the X, Y, and Z axes, while, as
turned for PP/OFF, curtails the process time shorter than that for
PP/ON.
[Simk]

Value which is calculated as the approximate of keratometer

value.

[Mink]

Actual shortest meridian.

[Ks]

The meridian of the largest refractive power and its value. (s of

Ks means steep)

[Kf]

The meridian perpendicular to Ks and its value. (f of

Kf means flat)

[Color map]

Map of curvature distribution which displays a corneal

shape with contour lines.

[Single map]

Color map which only displays either of the left and right eyes.

1-6

[Dual map]

Color map which displays both left and right eyes in one screen.

[Multiple map]

Color map which displays 4 eyes in one screen

[Absolute scale]

Absolute scale (ABS) employs the color distinction method,

which was developed by Professor Stephen D. Klyce of
Louisiana University (LSU).
Diopters between 9 and 100 are divided into 26 parts
distinguished with specified colors.
This scale shows the identical refractive values rated in the
same color positions for all measured eyes; therefore,
measured values can conveniently be referred to the refractive
values identified in the scale..
The central part of this scale, which is the normal range of
33.5D and 50.5D), is graduated with an interval of 1.5D by
placing 43D for normal eye at the center of the scale allotted
with yellowish color to greenish colors.
The upper and lower parts of this normal range are graduated
with an interval of 5.0D. The blue colors in the graduation of the
scale lower than the normal range increase its tone as the
refractive value decreases; on the other hand, those for upper
than the normal range gradually turn the red color into the
brighter color.

1-7

[Normalized scale]

The normalized scale (NRM) automatically allots the refractive

powers from the analytical results of the eyes examined in
different colors.
This scale is distinguished by colors covered within the range of
refractive values of measured eye as the results of analysis, in
order to interpret the configuration of a measured eye in detail.
The normalized scale allows nimble understanding of a corneal
configuration of measured eye. This scale shows a warm
color in the part for smaller corneal radius of curvature, while a
colder color in the part for larger corneal radius of curvature. This
implies that the corneas in a similar configuration show a similar
color map.
The refractive values of the normalized scale are divided in
eleven graduations. The larger difference between the highest
refractive value and the lowest refractive value, the wider range
of one color, while the smaller difference between them, the
narrower range of one color. The smallest interval of refractive
power is 0.4D.

Other glossaries are described in OPERATION PROCEDURES

1-8

1.4

Intended use
TMS-4N is an anterior segment analyzing system that is designed to capture topographer
measurements of the anterior segment of the eye to provide information including anterior cornea
topography, anterior cornea elevation maps.

1.5

Outline of operation
This Instrument is designed to capture Mire ring images projected onto the cornea
and to calculate a corneal shape and refractive power according to image analysis
by the personal computer. The results are shown on the color code map to ensure
easy and correct diagnosis.
This Instrument is provided with the light cone keratoscope with a short working
distance, which projects the reflection of the cornea in an interval of approximately
180 microns from the apex of the concentricshaped ring.
The Patient places his chin on the movable Chin Rest taking an easy posture. Press
the button provided at the upper part of the Joystick, to light the fixation lamp. The
patient looks into the cone, and then focuses his sight onto the fixation lamp. The
Physician checks the Patients cornea in the alignment monitor and next accurately
adjust the measuring position by looking at the reflections of the laser beam and the
target. The measured images are sent to an analyzing computer. Only the images
with good alignment are saved. Press the button of the joystick again to stop the
Picture Taking. This Map is next analyzed by the program capable of identifying the
positions of 256 points projected by respective rings. The data above are used for
calculating radius of curvatures and refractive values at each measuring point from
the information of respective position. All these pieces of information are saved in the
hard disk and displayed in respective color map.

1-9

This page is intentionally left blank.

1-10

2. NAME AND FUNCTIONS

2.1

Front side of the Instrument (Physicians side)

(1) Alignment Monitor
Displays the image of the anterior segment of the eye at
the time of picturetaking.

(1)

(2) Joystick Button

This button is pressed to start and stop the Picture Taking.

(2)

(3) Joystick

(3)

Move the measuring section up and down, left and right,

and upper and lower manually and adjust the position of
the Cone.

(5)

The Joystick is moved up and down.

(4)

(6)
(7)

(4) Fixing Screw at the Measurement Section

When moving or storing the Instrument, align its Upper and
Lower
Units and next clockwise turn and push the fixing screw.

(5) Power Lamp

Stays lit when the instrument is turned on.

(6) Chin Rest Switch

Pressing the UP and DOWN buttons moves the chin rest
up and down respectively.

(7) USB Connector

Terminal for connecting a personal computer using a
USB

2-1

2.2

Rear of the instrument (patient's side)

(1) Forehead RestAttachment Section

(1)

Have the Patient touch the Forehead Rest with his

forehead and next maintain an appropriate distance
between the Patient and the Instrument.

(3)

(2)

(5)
(4)

(2) Cone
Projects the concentric rings into the Patient cornea for
measurement.

(3) Eye Level Mark

Adjust the height of the Chin Rest to align the Mark to the
level of Patients eye.

(6)
(7)

(4) Chin Rest (Attachment Section)

Change the chin rest paper for a new Patient. Maintain
the chin rest clean.

(5) Power switch

Turns the main unit ON and OFF.

(6) Power connector

Connect a power cord here

(7) Fuse holder

Fuses are installed.

2-2

2.3

Icons on the screen

PRESS JOYSTICK BUTTON message

appears when Picture Taking is ready.
Pushing the button leads to the
Alignment Screen below.
Alignment Mark

Eye
OD: Right, OS: Left

Taken pictures
0 ~ 4 for each eye

Laser On

2-3

2.4

Symbols

Refer to instruction manual.

Caution

Power ON

Power OFF

Type B applied part

Grounding

Dangerous voltage

2-4

3. OPERATION PROCEDURES
3.1

Safety precautions

3.1.1

Precautions for installing the instrument

Install the instrument in a location free of water or chemicals. Any water or
chemicals entering the instrument may cause an electric shock or failure.
Do not install the instrument in a location where chemicals are stored or
gases may occur. Spilt chemicals or vapor may enter the instrument and
result in fire.
Do not hold the head, chin rest, forehead pad, joystick, or cables when
moving the instrument. These components are detachable and the instrument
may drop, resulting in injuries.
Install the instrument in a location not subject to direct sunlight, high
temperature and humidity, or air containing dust, salt and/or sulfur. Otherwise,
failure or malfunction may occur.
Install the instrument in a leveled stable location free of vibration or
mechanical impact. Otherwise, measurement cannot be conducted correctly.
Also, the instrument may topple over or fall down, resulting in fire or a serious
accident.
Install the instrument so that the user can use the system under the optimal
condition. Carefully connect the devices so that the wiring is not
disconnected unintentionally during operation, and does not hinder operation
of the instrument.

3.1.2

Precautions for connecting the power cord

Check the frequency, voltage, and allowable current (or power consumption)
of the power source. Otherwise, fire or electric shock may occur.
Connect the power plug to a grounded 3-pin outlet. Otherwise, a short circuit
due to failure of the instrument may result in electric shock.
Do not place any heavy object on the power cord or squash the power cord.
Fire or electric shock may occur.

3-1

3.1.3

Precautions for laser beam

During examinations, a low-power laser is used to position the patients cornea. The laser energy
entering the eye is quite small. But since laser light is potentially hazardous, the following safety
features have been incorporated into the instrument:
Each laser and its associated optics are enclosed in a sealed module within
the TMS-4N head, which is also sealed. There are no user serviceable parts
inside this sealed head. Do not attempt to open this unit for any reason. If the
unit fails, it must be returned to Tomey for service or repaired by authorized
personnel.
The laser beam exits the instrument through glass lenses located behind the
TMS-4N cone. Do not operate the instrument if these lenses become cracked
or broken.
Examinations should normally require no more than 15 seconds to complete.
If the TMS-4N is left in examination mode for more than 60 seconds, the
examination will be terminated and the lasers will automatically shut off.

3-2

3.2

Initial Setup

3.2.1

Release the VKS lock

Before using the TMS-4N, release the VKS platform lock by
turning the fixing screw counter clockwise.
Moving Joystick without releasing this lock cannot move the VKS
head.
Always lock the VKS platform before moving the TMS-4N.
Move the platform to the center of the base. Turn the fixing screw
clockwise until it engages.

3.2.2

Connecting accessories

a) Cone Insertion
Attach the cone to the measurement section.
Set the cone so that the sticker is at the top. Push the slits of the
cone against the three cone guides and turn the cone clockwise
until it stops.

b) Connect Cables
Connect Power Cable, Interface Cable and Printer Cable as shown in the picture.

Interface cable (supplied)

(To be connected to PC)

Power cord
(supplied)

c) Software Install
TMS-4N software works on the PC with certain Operating System. Please refer to 8.1
Specification.

3-3

3.3

Main Screen
When activating the TMS-4N software, the Main Screen is first displayed. You can optionally
access to various map displays, a new measurement, or to each program.

3.3.1

Name and function of Screen components

(Refer to 3.3.2 Details of functions in the Main Screen)

(1) Title bar

The name of the program being activated is displayed at the left end of the bar, while the
Minimization and Close buttons are displayed at the right end of the bar.

(2) Menu bar

Various operations are displayed with letters, of which each is hierarchically composed of
pull/down menus.

(3) Toolbar
General operations are displayed with visual icons to allow quicker operation than that from the
menu-bar.

(1)

(2)

(3)

(4) Setting of map options

Various maps are displayed with letters and buttons, of which selections are displayed by
pull/down menu.
(Temporary change of setting can be made while the Software is being activated. Setting of map
options when activating the Software is performed as prescribed by System Setup.)

(5) Patients list

yed by the save holder for Exam file of Patients or by the order of Patient names.

(6) Exams list

The List of Exams is selected (as reverse-highlighted) from the Patient list to display the list of
Exams files.

3-4

(7) Exam information area

Stats data and inherent information saved in the Exam files selected (reverse-highlighted) in the
Exam list are displayed.

(4)

(5)

(6)

(7)

3.3.2

Details of functions in the Main Screen

<Menu bar>

Each menu consists of the following pull/down menus.

File
New Patient P.

(Refer to 3.4.1 Patient Record screen).

The Window changes the display for registration of new Patient information.

Exam

(Refer to 3.5.1 Names and Functions of the Screen)

The Window changes the display for Exam from which the Patient can be chosen (as
reverse-highlighted) in the Patients List.

Quick Mode

(Refer to 3.5.3 Measurement with Quick Mode(Screening))

The Window changes the display for Exam without entering Patients data. This Mode is used for
test examinations without saving data.

Print Setup (Refer to 3.3.7 Printer setup)

Used to setup the Printer.

Print Query

(Refer to 3.3.7 Printer setup)

Prints the name of Patient, which has been extracted from the Database Query (Refer to 3.11.2
Database Query) and the information of Exams.

Exit
Ends the program.

3-5

Utilities
The following programs are entered from the menu. (Refer to 3.11.1 Structure of Utility Menu)
Database Query
Copy/Move/Delete
Link and Import
Data Tables
Reprocess Video
Patient List
System Setup
Make Stamp Maps
Calibration Verification
Regenerate State
VKS Table Import

Applications
The following applications are available from the menu. If an application is selected, the bucket
for selected application, which is located in the right lower part of the Main Window, is opened.
As for the information of each application. (Refer to 3.10 Other Map Display Methods and
Applications)
Power Difference
Klyce Statistics
Keratoconus Screening
Enhanced Height
Height Change
Contact Lens

Languages
The following nine different languages are contained in the menu, of which each screen is
displayed with related language.
English
Japanese
Italian
German
French
Spanish
Spanish Euro L.A.
Chinese
Portuguese
Custom Language

3-6

<Tool bar>

New Patient icon

Same function as New Patient in the File menu.

Exam icon
Same function as Exam in the File menu.

Quick Mode icon

Same function as Quick Mode in the File menu.

Keratoconus Screening icon

The bucket for Keratoconus Screening, which is located in the right lower part of the
Main Screen, is opened.

Dual Map icon

The bucket for Dual Map, which is located in the right lower part of the Main Screen, is
opened.

Multiple Map icon

The bucket for Multiple Map, which is located in the right lower part of the Main
Screen, is opened.

Custom Map icon

The bucket for application display, which has been set up by System Setup, is opened.
The application frequently used can be quickly opened from the toolbar.

<Map Option Setup>

Map Format

Map Type

Map Scale

Video Format

The Map Option, which is effective only while the Software is being activated, is set up in the
Main Window. (Refer to 3.8.1 Application of Map to Map Option Change)
Map Format button
Used for Topographic/Fourier/Numeric/3D-Model.

Map Type button

Used for Standard/Refractive/Instantaneous/Height.

Map Scale button

Used for Absolute/Normalized/Adjustable/Klyce/Wislson/ Maguire/Warning.

3-7

Video Format button

Used for Video off/Video Alone/Verify Mires/Background/Transparent.

<Patient List>

The Patient List is shown with the information of last names, first names and Patient ID numbers
in their respective grid, which are displayed in two ways: one shows each folder having the Exam
files and the other does the list of Patients, which are switched over by the check box of Folder.
In case of displaying information by each folder, the Patients are sorted by their last names. In
case of the Patient List, upstream or downstream listing order of their last names are
automatically switched alternately by clicking each grid. The Patient Query system of this
Instrument retrieves the row of letters entered with the keys for Patient information, which has
been entered in the effective grids as selected, whatsoever any retrieving method may be used.
Click the Patient info button when opening the Patient Record Window (for Patient information).
(Refer to 3.4.1 Patient Record screen)

<Exam List>
The Exam List shows the list of all the information of examinations given for Patients. (In case the
list of Patients is saved in the folder, the list of Exams stored in the folder will be displayed).

The following information is displayed in the screen of Exam List.

3-8

Cone

Type of cone

Eye

Eye to be measured

Date Time:

Date and time of measurement

File Name

File name of measured data

Path

Place where the data is saved

Exam#

Measurement number and type of measuring equipment

Measurement data saved in the hard disk of the personal computer are displayed in black. If
measurement data have already been moved to an external memory medium and its disk has not
been set, or if its disk has not been set with the imported data from the external memory medium
to the Link and Import, File Name and Path will be displayed in red. In case the red colored
measurement data are selected and relevant map is intentionally opened, the message indicating
to set the external disk will be displayed.

Information
New measurement data, stored on the external disk can be added to the Exam list by using the
Link and Import function. (Refer to 3.11.4 Link and Import)
Copying, Moving, or Deleting of measurement data to and from an external disk is performed by
using the Copy/ Move/Delete function. (Refer to 3.11.3 Copy / Move / Delete)

<Exam Information Area>

Inherent information of each Exam is entered and displayed. The information of an Exam selected in
the Exam List, which is highlighted in the list, is entered and displayed. Double-clicking of the field in
the un-activated condition activates Enter/Select. The information entered or corrected can be saved
in or deleted from the Exam file with the Save or Cancel buttons.
Stats Information (basic corneal statistical indexes) displays the following information. (Refer to
3.10.5 Klyce Corneal Statistics)
Ks
Displays the direction and value of the meridian having the largest refractive power. (s of Ks
represents the initial letter of steep). If the difference between the strong and the week
meridien is less than 0.2D, Spherical will be displayed.

Kf
Displays the direction and the value of the meridian crossing at a right angle to Ks. ( f of Kf
represents the initial letter of flat).

MinK
Displays the direction and value of the meridian having the smallest refractive power.

AveK
Displays the average of Ks and Kf refractive powers.

Cyl
The difference between Ks and Kf is displayed as a corneal cylindrical component, which is
expressed in diopter unit.

3-9

SRI
Displays Surface Regularity Index.

PVA
Displays expected maximum visual accuity.

SAI
Displays Surface Asymmetry Index.
information.

Exam Label is input and displayed with the following

Refraction field
Refractive values (Sph: spherical power, Cyl: astigmatism power, Axis: astigmatism axial angle)
are input and displayed.

BCVA field
BCVA (corrected visual accuity) is input and displayed.

Diag (Diagnosis Code) field

Diagnosis, which have been registered in the System Setup, are select-input and displayed.

Group field
Group (category names of measurement results), which has been registered in the System
Setup can be selected and displayed.

Operator field
Operator (names of examiners), which has been registered in the System Setup, is select-input
and displayed.

Note (Exam Note) field

Special notes and comments for measurement results are entered and displayed.

Clinic Name
Clinic Name registered in the System Setup when measurement was taken is displayed.

Disk Label
Displays the name of external memory media, if Exam is moved to the external memory media
(FD, CD-R/RW, etc.) by the function of Copy/Move/Delete or when it is linked from the external
memory media by the function of Link and Import.

Machine ID
Information of the Machine ID is recorded to identify the models of the original Exams and the
names of files, when the Exams of which pictures taken by other instrument are Link and Import.

3-10

3.3.3

Map Display
The TMS-4N Software provides eleven patterns of map display and application function, including
a single map and the following patterns. Data pictures taken are selected and displayed so as to
meet the purpose, chosen from these displays and application functions. Each of the map
displays and the application functions can be set by map options for more detail information.
(Refer to 3.9.1 Setup of Map Options)
<Single map>

Single Map can also be displayed by double-clicking the reverse highlighted measurement data
from the Exam List. If Fourier is selected at Map Option Setup of Main Screen, Fourier Map
will be displayed. (Refer to 3.8.2 Map Format)
<Other Map Displays> (Refer to 3.10 Other Map Display Methods and Applications)
-Dual Map
-Multiple Map
-Map/Video Review
<Application Functions>
-Power Difference
-Klyce Corneal Statistics
-Keratoconus Screening
-Enhanced Height
-Height Change
-Contact Lens

3-11

3.3.4

New Patient Registration

Select New Patient from the File menu to display the screen of Patient Record. Enter necessary
information of a particular patient into New Patient. (Refer to 3.4.1 Patient Record screen)

3.3.5

Measurement (Picture-taking and Analysis)

For taking measurement (Picture-taking and Analysis), change the screen to that for Capture by
the following procedure.
Select the name of Patient to be examined (reverse-highlighted) from the patient list and
in the toolbar).
next Exam in the File menu. (You may also click the Exam icon
Double-click the name of the Patient to be examined.

Printing of Database Query information

3.3.6

The patient list extracted from the Database Query in the Utilities can be printed. After a certain
patient or an Exam is selected, Query Patient List will be displayed by selecting Print Query
shows Printer Selection dialog and printing will be
from File menu. Clicking Print icon
done accordingly.

3-12

3.3.7

Printer setup
Select Print Setup from Fire menu, Windows standard printer will start.

* The formal name is Microsoft Windows operating system. It refers to Windows in this document.

3-13

3.4

Patient Record
Information of a new patient can be registered, checked and corrected, on Patient Record
screen. Numbers in ( ) show the maximum number of letters of single byte.

3.4.1

Patient Record screen

(1)Last Name (20)

Crucial

Patient last name is entered and displayed.

(2)First Name (20)

Patients first name is entered and displayed.

(3)ID# (20)

Crucial

Patients ID number, insurance number, etc. is entered and displayed.

(4)Sex
Sex (male or female) is selected.

(5)DOB
Patient date of birth is entered and displayed.

(6)First Seen
First examination date (Patient Record) is entered and displayed.
(1)
(3)
(4)
(5)
(6)

(7)Address

(2)

(30, 15, 10)

Patients address is entered and displayed.

(8)Zip

(10)

Patients mail zip code is entered and displayed.

(9)Tel(H)

(15)

Patients home telephone number is entered and displayed.

(10)Tel(O)

(15)

Patients business telephone number is entered and displayed.

3-14

(11)Note

(255)

Patients special information and physicians comments are entered and displayed.

(12)Do Exam button

Patients data are saved and the screen is changed to that for that patients examination.

(13)Save & Next button

Entered and corrected data are saved and the screen is changed to the main screen.

(14)Back button
Entered or corrected data are not saved, but deleted.

(7)
(8)
(9)
(10)
(11)

(12)

3.4.2

(13)

(14)

New Patient Registration

1) Select New Patient from the File in the Main Window, so the Patient Record with all blank fields
will be displayed. (Only the First Seen has already filled with information according to the
system setup of the Windows).
2) Enter necessary information with the keyboard. Click on the blank field with the mouse or press
the Tab key of the keyboard to move the field for entry from one to the other.
3) Click the Do Exam to save patients information, by which all entered patient information is
saved, by which all the information that has been stored is cleared at the same time, except for
First Seen. This process is used to successively register Patient information. Clicking on the
Back button returns the screen to the Main Screen, without saving entered patients
information.

3.4.3

Checking and correcting of Patients Information

For checking or correcting of saved patient information, select the patient in subject from the
patient list and click the Patient info. button. Enter or correct the information in a similar manner
to that for new Patient registration.
If all the Exams of the patient are not at the rewritable status, correction cannot be done.

3-15

3.5

Capture Screen (Picture Taking)

New pictures are taken at Capture screen. Control of picture taking (Input) and Output is
performed at Capture screen.

3.5.1

Names and Functions of the Screen

(1) Patient Information
Patient name and Patient ID are displayed.

(2)Cone Type
25 ring cone or 31 ring cone is set according to the cone to be used. 25 and 31 are switched at
pull down menu.

(3) Used Device

The serial number of the TMS to be used is displayed. If two and more units of the TMS are
connected, the unit to be used is selected at pull down menu.

(4) Dual Map Icon

When one analysis at least is completed, it becomes effective. A Dual Map is made with the
Exams of the upper two eyes.

(1)

(2)

(3)

(4)

(5) Picture Selection Button

The picture to be displayed on the screen is selected with this button. The bar showing the Exam
moves in connection with the button selection. And the selected picture( with the button pressed)
always appears on the top. The buttons are numbered like 1, 2, 3 from the least offset at
picture taking. If the lowest picture is selected, no other pictures are displayed under it. + mark
beside the picture selection button means that analysis is completed.

(6) Alignment Control

This is the slide bar to change the threshold of alignment offset that is one of the conditions to
take a picture. Slide the bar upward to increase the threshold and downward to decrease the
threshold. If the threshold is set higher, a picture with less offset can be taken, but it gets harder
to take it.

3-16

(7) Picture Perfect

ON/OFF of Picture Perfect is set.
If it is set ON, pictures are taken with the condition set in F. If it is set OFF, a picture is taken
only when the joystick is pressed.

(5)
(6)
(7)

(8) Shooting Timer (Remaining)

The residual time for picture taking is shown. It counts down form 60 seconds.

(9) Caption Button

This button controls Start/Stop of picture taking of TMS main unit. It automatically gets Start
status when you get in Capture Screen. When 4 pictures have taken for each eye, it
automatically becomes Stop status.

(10) PreMap Button

Pressing this button opens PreMap screen where 4 images of each eye can be displayed.

(11) Taken Pictures Displaying Area

Taken picture of OD on the left and of OS on the right are displayed. When picture taking is
finished, the images with less offset appear on upper side. The Exams of which analysis is over
are overlapped with a color map. Right down corner of each image is shown the offset at the
picture taking.

(11)

(10)

3-17

3.5.2

Picture Taking
1) Press the joystick button after checking if the correct cone type is selected at the screen.
2) Align the machine on the patients eye while observing the live image on the alignment monitor
of the main unit.
3) Images are transferred into the analyzing PC with a beep.
The right eyes are displayed on the left part of the screen and the left eyes on the right
according to the order of shooting.
4) The best shot of each eye is displayed on the top after taking 4 images of both eyes or pressing
Caption button (Stop).
5) In order to select the picture for analysis, display a forecast map of the picture by pressing
PreMap button or double click the picture to display the result of analysis.
6) If there are Exams of which eyes have been analyzed, the Dual Map button displayed the dual
map of right and lest eye. The Exams appearing on the upper side of the screen are displayed.
7) Press Closing button to go back to Main screen by canceling or finishing Caption.
Caption may be difficult because of deformation of central part of cornea. In
this case put the alignment bar down and try again. If it is still difficult, make
Picture Perfect OFF and take pictures manually (with the joystick button).
The Exam taken manually is not compensated with offsets. This means
correct results may not be displayed.
The captured pictures not analyzed will be discarded.

Measurement with Quick Mode(Screening)

3.5.3

Quick Mode doesnt need Patient information to do measurement (picture taking). It can be used
for trial measurement without saving data.
1) Selecting Quick Mode at File menu of Main Screen leads to Capture screen. The Capture
screen with Quick Mode doesnt show the patients name. It shows All Clear, Save icons in
it.

3-18

2) Click Save button to save the Patient Information in Exam data after picture taking and
analysis.
Once Patient Information is set, all the taken pictures and analyzed data
appearing on Capture screen are handled as the data of that patient. (Mode
is changed from Quick Mode to Normal Mode).
Press All Clear button to measure another Patient without setting
Patient information on the Exam data. All the taken pictures and
analyzed Exams are discarded and an empty Capture screen is prepared.
The measured data is not automatically saved with QuickMode.

3) Pressing Save button opens Save Exam window.

In case the patient is already registered in the database select the patient name from the Patient
list and click Add to Selected button.
In case a new patient is registered, click NewPatient and enter the necessary information at
Patient Record screen. (Refer to 3.4.1 Patient Record screen)

3-19

3.6

PreMap Screen
On PreMap Screen, all of the 4 pictures taken on Capture Screen are displayed for each eye.
Each image is displayed at Transport Map Mode after automatic analysis and repeatability of
measured eyes can be confirmed.

3.6.1

Names and Functions of the screen

(1) Patient Information
The name of the patient and Patient ID are displayed.

(2) Indication of Measured Eyes(OD/OS)

Right eye or lest eye in indicated to know which is measured

(3) Color Scale

The scale used in the map display is shown with its type and unit.

(4) Pictures displaying area for one eye.

Taken pictures of one eye are displayed from upper left to lower right with time sequence. The
image of which analysis is completed is displayed with a map in Background mode. Offset is
shown in the down right and Analyzed Area (AA), the area where analysis is possible, down left
of each image.
(1)

(4)

3-20

(2)

(3)

3.7

Exam Screen (Analysis)

Analysis of taken pictures are performed on Exam Screen

3.7.1

Names and Functions of the Screen

(1) Used Device
The serial number of the main unit used for picture taking is displayed.

(2) Date of Analysis

Date and time when Exam screen is opened is displayed.

(3) Cone Type

The type of cone used is displayed.

(4) Measured Eye

The eye analyzed is indicated with OD/OS.

(5) PP(Picture Perfect)

The status of Picture Perfect at picture taking is displayed.

(6) Patients Name

The patients name analyzed is displayed.

(7) Offsets
Error at each direction of XYZ axes at picture taking is displayed.

(1)
(2)
(3)
(4)
(5)
(6)

(7)

(8) Message Field

Status of analysis is displayed.

(9) Button Box

Buttons to control the analysis.

3-21

(10) Video Window

Analyzed mire rings and a taken picture are displayed.
(10)

(8)

3.7.2

(9)

Button Box
The following buttons are displayed in the button box depending on each measurement process.
Mires OK Button
It starts analysis for displayed picture.

Manual Button

(Refer to 3.7.4 Manual Center (Centering manually))

In case the corneal center cannot be found from the taken picture, the center is set manually with
this button.

Cancel
It stops the analysis to go back to PreMap or to Capture screen

Process Anyway Button

(Refer to 3.7.7 Offsets)

This button is displayed in case the analysis center is dislocated. Pressing this button starts
analysis with the center dislocated. The reliability of the data in this case is low.

3.7.3

Analysis
1) Double clicking a taken picture on PreMap or Capture screen displays Exam screen.
2) The program evaluate the image quality objectively. If the program judges that the alignment is
shifted, it corrects automatically. After that, the rings of the taken picture is scanned.
3) Analyzed ring data are plotted in green (Mires) on the corneal picture. Offsets of X/Y/Z axes are
displayed down right of the screen.

3-22

4) Click Mires OK button after checking if the center of the Mires (plotted green dots) coincides
with the center of the taken video image (in case of proper alignment) and if there is no gaps
between each ring and the green dots. The image is automatically saved.
If the Mires do not trace the projected rings properly, wrong result of
analysis may be given. It is advised that in case the color maps of right and
left eye are very different or the shape of the cornea is indicated as steep or
flat in which the center shape of the cornea is very different from the
peripheral, diagnosis be made synthetically using not only the result of
this instrument but also with other information.
-

In case the date appearing upper right is different from the actual date, set the date at
Windows and try again.

5) After analysis, a map is displayed on Single Map.

6) In case the center of Mires and the ring center of the video image do not coincide, select
another taken picture for analysis or do picture taking again. In that case, tell the patient blink
several times to make the corneal surface wet.

3-23

3.7.4

Manual Center (Centering manually)

The center of analysis may be recognized incorrectly. In this case click Manual button and put
the cursor (an arrow) at the center of the rings and click. The analysis is performed again with the
newly set center. In case the center of analysis cannot be found, a message Center not found.
Please click on rings center. is displayed. Put the cursor (an arrow) at the center of the rings with
the mouse. In case Misalignment too great for accurate results is displayed, select another
taken picture or take a picture again. Data which is made by setting the analysis center with
Manual shows NC on the corresponding maps.

3.7.5

Analyzing another eye

When analyzing another eye, go back to Capture screen and double click the taken picture of
another eye or show PreMap screen and start Exam screen.

Data Saving

3.7.6

The measured data and images taken at Exam screen are saved automatically at pressing
Mires OK button.
Data cannot be saved automatically at Quick Mode.

3.7.7

Offsets
After analysis, the program sets the laser position and checks the dislocation of alignment. The
dislocation is displayed down right of the screen.

3-24

X, Y, Z offsets are colored as follows.

Green : The value is within the tolerance (<0.3 mm)

Yellow : The value is on the border(0.3 - 0.4 mm)
Red

: The value is out of tolerance(0.4mm)

Compensation may not be possible.

A vector of alignment shift is also calculated as well as X, Y, Z values. If this value is out of
tolerance (PP On: >0.3mm, PP Off: >0.125mm), Misalignment too great for accurate results. is
displayed and vector offsets are displayed in red above the offsets.
Even if three of offsets are within tolerance, alignment shift may be out of
tolerance as a whole.
If a message related to alignment shift is displayed, analyze other Exams or select Process
Anyway.
Cautions for selection of Process Anyway
Even if measurement is performed, correction program may not compensate the alignment shift.
Although maps quality looks good (if the corneal curvature is as a whole displayed correctly),
numerical data may not be correct. Therefore the statistics (SimK, ACP, CEI etc.) obtained
under such circumstances are not reliable very much and they are not used for IOL selection or
contact lens fitting.
After finding the center and finishing compensation of alignment shift, ring detection is performed
and the program sets 256 points on each ring and plots the analyzed ring data on the original
video data. At this time, if Pupil Demarcation is set in System Setup, outline of the pupil is plotted
in blue on the video image. The interporated pupil data are plotted in red. (Refer to 3.11.8
System Setup)
After ring treatment, a message is displayed prompting to check the Mires (green rings).
If Mires do not on the original video rings (the green dots dont stand on the video rings), the data
on the map is not correct. In this case, select another picture or ask the patient to blink several
times and continue taking pictures until the best analysis is obtained.

3-25

3.8

Map Screen

Names and functions of map components

(1)
(2)
(3)

(9)
(5)
(4)

(7)
(8)

(6)
(12)
(13)

(12) (11)

(1) Patinet Information

Major information LastName, FirstNameand PatientID are displayed.

(2) - (6) Exam proper information

Exam Proper information (2) Measurement Date (3) Measured Eye OD/OS (4) Clinic Name (5)
File Name.

(6) Pupil Information

Outline of the pupil, its center and its offset are displayed.

(7) PP(Picture Perfect)

The Exams with PP ON are displayed.

(8) Offset
Alignment errors in X, Y, Z directions at picture taking are displayed.

(9) Map Type

The present map type is displayed. It can be changed at the menu appearing at clicking the
mouse.
Standard/Refractive/Instantaneous/Height

(10) Map Scale

The present scale type is displayed. It can be changed at the menu appearing at clicking the
mouse.
Absolute /Normalized/Adjustable/KlyceWilson/ MaguireWaring/ Custom

(11) Map Unit

The present unit is displayed. It can be changed by clicking the mouse.
Diop/mm

3-26

(12) Print Button

Map print can be performed. There are two icons for Preview and Direct Printing.

(13) Basic Statistical Indices

The following basic statistical indices of cornea are displayed.
Ks/Kf/Mink/AveK
Es/Em
Es: Eccentricity of an ellipse approximating the corneal shape at the meridian of Ks.
Em: Eccentricity of an ellopse approximating the corneal shape at the meridian of MinK.
These values are positive when the center part of the cornea is steeper that the peripheral and
negative when the center part is flatter than the peripheral.
Cyl/SRI/SAI/PVA/SAI

3.8.1

Application of Map to Map Option Change

Maps can be displayed by ten types of map display methods or application functions (Refer to
3.10 Other Map Display Methods and Applications), of which each map can be displayed at
option (Refer to 3.9.1 Setup of Map Options), (including map format, map type, scale, and unit.)
When activating the software, these defaults are setup by System Setup. Change in these options
can also be made in the Map Screen or by Map Option Setup (Refer to 3.3.2 Details of functions
in the Main Screen) in the Main Screen. Application of changes are as follows:

Change in the Map Screen

Map change can be made only while in process of map display. Once the map is closed, the
Screen will return to the default setup.

Map option setup of Main Screen

Map change is always made while the Software is in activation. (After restart of the software, the
setup at System Setup is avail able.)

3.8.2

Map Format
The map is displayed with four types of format. The change of these four types can be made in
Map Options Setup (Refer to 3.3.2 Details of functions in the Main Screen) or in Map Options
Menu appearing at right clicking the mouse.
Topographic Map/Corneal Shape Map
The refractive power, radius of curvature, and height of a cornea are displayed in color scales.
The cold color (bluish color) in the scale shows the flat portion of the cornea, while the warm
color (reddish color) does its inclined portion.

3-27